Identity
- Trade Name
- Patient Circuit - Pediatric, 2.4m, 1 pcs FDA UDI
- Generic Name
- Inspiratory/expiratory limb respiratory tubing, single-use FDA UDI
- Model / Reference
- VWSP-390 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290017096902 FDA UDI
- 510(k) Number
- K202970 FDA UDI
- FDA Product Code
- CBK FDA UDI
- GMDN Term
- Inspiratory/expiratory limb respiratory tubing, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Inspiratory/expiratory limb respiratory tubing, single-use
Patient Circuit - Pediatric, 2.4m, 1 pcs by Inovytec Medical Solutions Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Inspiratory/expiratory limb respiratory tubing, single-use.
- Anesthesia — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Anesthesia — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Anesthesia — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Transcend — SOMNETICS INTERNATIONAL, INC · Class I
- Anesthesia — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Anesthesia — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Anesthesia — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Anesthesia — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
Cleared under the same submission
K202970 also covers:
- Inlet Filter - Regular — INOVYTEC MEDICAL SOLUTIONS LTD
- Patient Circuit - Adult, 2.4m, 1 pcs — INOVYTEC MEDICAL SOLUTIONS LTD
- Patient Circuit - Pediatric, 1.8m, 1 pcs, one way — INOVYTEC MEDICAL SOLUTIONS LTD
- Ventway Sparrow — INOVYTEC MEDICAL SOLUTIONS LTD
- Ventway Sparrow MRI — INOVYTEC MEDICAL SOLUTIONS LTD
- Ventway Sparrow MRI Packaged — INOVYTEC MEDICAL SOLUTIONS LTD
- Ventway Sparrow MRI Robust Packaged — INOVYTEC MEDICAL SOLUTIONS LTD
- Ventway Sparrow Packaged — INOVYTEC MEDICAL SOLUTIONS LTD
- Ventway Sparrow Robust — INOVYTEC MEDICAL SOLUTIONS LTD
- Ventway Sparrow Robust Packaged — INOVYTEC MEDICAL SOLUTIONS LTD
- Ventway Sparrow Robust Ventilator MRI Compatible — INOVYTEC MEDICAL SOLUTIONS LTD
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inovytec Medical Solutions Ltd
Sources (1)
- FDA UDI 66c2f44a-d0e3-446a-b722-2149e196f51c 34 fields · synced Jun 1, 2026